BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY QUADRA CRT-D, DF4 CONNECTOR

    MDR report key: 3090017 · Received May 2, 2013

    Report

    Report Number
    2938836-2013-01234
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    February 6, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE REPORTED CAPTURE ANOMALY WAS CONFIRMED IN THE LABORATORY VIA REVIEW OF DEVICE PRINTOUTS. THE DEVICE WAS TESTED MANUALLY ON THE BENCH AND USING AUTOMATED TEST EQUIPMENT AND WAS FOUND TO BE NORMAL. NO ANOMALY WAS FOUND. THE CAUSE OF THE FIELD REPORTED EXPERIENCE OF A CAPTURE ANOMALY COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT STATED FEELING FLUTTERY SENSATION WHEN LYING ON THEIR SIDE. LV LEAD DISLODGEMENT WAS NOTED AND ICD MIGRATION WAS SUSPECTED. DURING REPLACEMENT, NO CAPTURE WAS OBSERVED WHEN LEAD WAS PUT INTO HEADER HOWEVER ALL OTHER LEADS WORKED WELL. ICD WAS EXPLANTED AND REPLACED. PATIENT CONDITION AFTER THE EVENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191695 UNIFY QUADRA CRT-D, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3251-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention (B)(4)